Deutetrabenazine

Deutetrabenazine comes as a tablet to take by mouth. It is usually taken with food once a day at first and then increased to twice a day. Take deutetrabenazine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deutetrabenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of deutetrabenazine and gradually increase your dose, not more than once every week.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking deutetrabenazine,

• tell your doctor and pharmacist if you are allergic to deutetrabenazine, any other medications, or any of the ingredients in deutetrabenazine tablets. It works by changing the activity of certain natural substances in the brain. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking reserpine, tetrabenazine (Xenazine), or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking a monoamine oxidase inhibitor within the past 2 weeks or stopped taking reserpine in the last 20 days. Your doctor will probably tell you that you should not take deutetrabenazine.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for anxiety; antidepressants such as bupropion (Aplenzin, Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem, Selfemra), and paroxetine (Brisdelle, Paxil, Pexeva); antipsychotics such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon); certain medications for irregular heartbeats such as amiodarone (Cordarone, Nexterone, Pacerone), procainamide, quinidine (in Nuedexta), and sotalol (Betapace, Sorine, Sotylize); moxifloxacin (Avelox); medications for seizures; sedatives, sleeping pills, or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have liver disease. Your doctor will probably tell you not to take deutetrabenazine.
• tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death) or another type of irregular heart beat or heart rhythm problem. Also tell your doctor if you have or have ever had low blood levels of magnesium or potassium in your blood or breast cancer.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking deutetrabenazine, call your doctor.
• you should know that deutetrabenazine may make you drowsy or cause tiredness. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking deutetrabenazine.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

If you miss taking deutetrabenazine for more than a week, talk to your doctor before starting to take it again. You will probably have to restart taking it at a lower dose.

>10%

Somnolence (11%)

1-10%

Diarrhea (9%)

Dry mouth (9%)

Fatigue (9%)

Urinary tract infection (7%)

Insomnia (7%)

Anxiety (4%)

Constipation (4%)

Contusion (4%)

Dizziness (4%)

Akathisia, agitation, or restlessness (4%)

Depression (4%)

Suicidal ideation (2%)

Deutetrabenazine may be found in some form under the following brand names:

• Austedo

This is not a complete list of Deutetrabenazinedrug interactions. Ask your doctor or pharmacist for more information.

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

• Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of deutetrabenazine is 36 mg per day (18 mg twice daily).1

• Alcohol or other sedating drugs: May have additive sedation and somnolence.1

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For deutetrabenazine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to deutetrabenazine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of deutetrabenazine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of deutetrabenazine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving deutetrabenazine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking deutetrabenazine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using deutetrabenazine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Mesoridazine
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Pimozide
• Piperaquine
• Procarbazine
• Rasagiline
• Reserpine
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Tetrabenazine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using deutetrabenazine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bupropion
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Itraconazole
• Ivabradine
• Ketoconazole
• Lapatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mizolastine
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Terbinafine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of deutetrabenazine. Make sure you tell your doctor if you have any other medical problems, especially:

• Akathisia (a movement disorder), including agitation and restlessness, history of or
• Depression, history of or
• Heart rhythm problems (eg, QT prolongation), history of or
• Suicidal thoughts or behavior—Use with caution. May make these conditions worse.

• Bradycardia (slow heartbeat) or
• Breast cancer, history of—Use with caution. May increase risk of serious side effects.

• Depression, untreated or
• Liver disease or
• Suicidal thoughts or behavior, active—Should not be used in patients with these conditions.

• It is used to treat disabling involuntary movements in Huntington's chorea.
• It is used to treat tardive dyskinesia.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling tired or weak.
• Loose stools (diarrhea).
• Dry mouth.
• Not able to sleep.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

(du tet ra BEN a zeen)

Poor CYP2D6 metabolizers: It is likely that the exposure to alpha-HTBZ and beta-HTBZ would be increased ~3-fold.

Hepatic impairment; patients who are suicidal or who have untreated or inadequately treated depression; coadministration with tetrabenazine; coadministration with or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs); coadministration with or within 20 days of discontinuing reserpine.

Applies to deutetrabenazine: oral tablet

Along with its needed effects, deutetrabenazine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking deutetrabenazine:

• Body aches or pain
• chills
• diarrhea
• difficulty with breathing
• difficulty with swallowing
• discouragement
• drowsiness
• dry mouth
• fear or nervousness
• feeling sad or empty
• fever
• headache
• inability to sit still
• irritability
• lack of appetite
• loss of balance control
• loss of interest or pleasure
• mask-like face
• need to keep moving
• relaxed and calm
• restlessness
• shuffling walk
• sleepiness or unusual drowsiness
• slow movement or reflexes
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• tiredness
• trembling and shaking of the fingers and hands
• trouble concentrating
• trouble sleeping
• trouble with balance
• unusual tiredness or weakness

• Dizziness
• problems passing stools

Get emergency help immediately if any of the following symptoms of overdose occur while taking deutetrabenazine:

• Blurred vision
• confusion
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fixed position of the eye
• inability to move the eyes
• increased blinking or spasms of the eyelid
• mood or mental changes
• nausea and vomiting
• seeing, hearing, or feeling things that are not there
• shakiness in the legs, arms, hands, or feet
• sticking out of the tongue
• sweating
• trembling or shaking of the hands or feet
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions

Some side effects of deutetrabenazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bruising
• large, flat, blue, or patches in the skin

Data not available.

Administration Advice:
-Administer with food.
-Swallow drug tablets whole; do not chew, crush, or break tablets.

Storage Requirements:
-Store at 25 degrees Celsius (77 degrees Fahrenheit); excursions permitted to 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).
-Protect from light and moisture.

General:
-Overdosage: Provide supportive care and consider the possibility of multiple drug involvement in managing overdose.

Monitoring:
-General: Periodically re-evaluate the need for this drug by assessing the effect on chorea and possible adverse effects.
-Nervous System: Signs and symptoms of akathisia, restlessness, and agitation.
-Psychiatric: Signs and symptoms of new or worsening depression, suicidality, or unusual behavior changes.

Patient Advice:
-While taking this drug, avoid alcohol and potentially dangerous activities such as driving a car or operating machinery until you know how this drug affects you.